Multisite Controlled Trial of Cocaine Vaccine

Summary

The purpose of this study is to test the efficacy of a newly developed active vaccine against cocaine (TA-CD).

Conditions

• Cocaine Dependence

Interventions

DRUG

TA-CD Vaccination

On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor.

OTHER

Placebo Injection

On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• US Department of Veterans Affairs Cooperative Studies Program

  collaborator NETWORK

• VA Maryland Health Care System

  collaborator FED

• Columbia University

  collaborator OTHER

• VA New York Harbor Healthcare System

  collaborator FED

• University of Pennsylvania

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Celtic Pharma Development Services

  collaborator INDUSTRY

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Thomas R Kosten, M.D. · Baylor College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2012-08-31

Completion

2014-07-31

Countries

• United States

Study Locations